STAR Clinical Trial Controversial Among Some Advocacy Groups

STAR Clinical Trial Controversial Among Some Advocacy Groups

The NCI brushed aside the concerns of some
cancer advocacy groups and decided to begin the Study of Tamoxifen
and Raloxifene (STAR),expected to be one of the largest breast cancer
prevention trials ever. Raloxifene (Evista) was approved by the FDA
in December 1997 to prevent osteoporosis. Tamoxifen (Nolvadex)
received FDA approval in October 1998 to reduce the risk of breast
cancer in women at high risk for the disease. The STAR trial will
compare the impact of the two drugs on women at risk for breast
cancer, with particular emphasis on side effects. Women in previous
trials of both raloxifene and tamoxifen have shown an increased
incidence of deep vein thrombosis and pulmonary embolism, but
raloxifene has not produced the endometrial cancer risk that
tamoxifen has.

In announcing STAR, Donna Shalala, secretary of the Department of
Health and Human Services, said, Women who are at high risk of
developing breast cancer need more and better prevention options, and
only through clinical trials such as STAR will we find those
options. But groups such as the National Breast Cancer
Coalition have strong reservations. The group said in a statement:
What we do know about tamoxifen as risk reduction is known only
for the population of women who actually enrolled in the tamoxifen
prevention trial. It is inappropriate to study a different population
of healthy women as planned for the STAR trial.

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